Parkinson Disease
Conditions
Keywords
Parkinson's Disease ande Video Games
Brief summary
Patients with Parkinson's disease present motor dysfunctions such as stiffness, tremor, postural instability and bradykinesia, which leads to alterations of balance, necessitating specialized physiotherapeutic treatment. In this way this study aims to determine the effectiveness of two tools used in physiotherapy, kinesiotherapy and the Nintendo Wii. 45 patients will be evaluated through the Berg Balance Scale, Dynamic Gait Index, Timed up and go and PDQ-39, and will then be randomized to receive 16 sessions of Exercises or Nintendo Wii alone or together. After this period the patients will be reassessed to verify the effects of the techniques.
Detailed description
Patients with Parkinson's disease present motor dysfunctions such as stiffness, tremor, postural instability and bradykinesia, which leads to alterations of balance, necessitating specialized physiotherapeutic treatment. In this way this study aims to determine the effectiveness of two tools used in physiotherapy, kinesiotherapy and the Nintendo Wii. 45 patients will be evaluated through the Berg Equilibrium Scale, Evaluated by the Dynamic Gait Index and the Timed up and go and PDQ-39. Later patients will be randomized to receive 16 sessions of Kinesiotherapy or Nintendo Wii alone or together, twice a week, for 50 minutes at the Neurociencias Outpatient Clinic of Teacher Magalhães Neto - FUBA. After this period the patients will be reassessed to verify the effects of the techniques.
Interventions
A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training
Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game
In GCW program will be performed 20 minutes GC protocol (1 or 2, used alternately between sessions a week) and 20 minutes GW protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols
Sponsors
Study design
Masking description
Single Blind (Outcomes Assessor)
Eligibility
Inclusion criteria
* Age between 40 and 80 years, * Stage 1 to 3 on the Hoehn and Yahr scale, * Absence of visual or auditory impairment,
Exclusion criteria
* Presence of cognitive alterations according to MEEM: illiterate 19 points; 1 to 3 years of schooling 23 points; 4 to 7 years 24 points and above 7 years of 28 points * Presence of other neurodegenerative diseases, * Uncontrolled osteomioarticular or chronic diseases * Participation in other rehabilitation programs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Scale | 8 weeks | It is a scale that allows a functional assessment of the balance of the performance. It is based on 14 common items of everyday life, graduated from 0 to 4 points, reaching 56 points maximum score. It presents test reliability and re-test of 98%, another particularity of the scale is the non-linear relationship between the score and the risk of corresponding falls. The scores range from 0 to 56, the higher the score, the better the assessed individual's balance. Each point less on the scale corresponds to an increased risk of falls; between scores 56 to 54, each minus point is associated with a 3 to 4% increase in the risk of falls; between 54 and 46 an increase of 6 to 8% of chances for each point, being that below 36 points the risk of falls is almost 100% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Gait Index - DGI | 8 weeks | It is a scale that allows a functional assessment of the balance of the performance. Comprising 8 tasks with a score ranging from 0 to 3 points, maximum score of 24 points and minimum score of 0 points It consists of eight tasks involving walking in different sensory contexts, which include flat surface, change in gait speed, horizontal and vertical head movements, overpassing and bypassing obstacles, turning over the body axis itself, going up and down stairs . The maximum score is 24 points, and a score of 19 points or less predicts risk of falls. The scale has no gaps, only cutoff points. The higher the value, the better the gait performance. For patients with Parkinson's disease, values below 19 points predict major gait problems and high risk of falls. |
| Timed Up and Go - TUG | 8 weeks | The TUG measures, in seconds, the time it takes an individual to lift from a standard armchair (height of approximately 46 cm), walk a distance of 3 meters, turn, walk back to the chair and sit again. The patient is asked to lift from a chair (seat height of 45 cm and arms from 65 cm) to walk 3 meters, return and sit again, while the time spent in performing this task is timed. TUG up to ten seconds - individual without change of balance and with low risk of falls; (2) TUG between 11 and 20 seconds - individual with no significant alteration of balance, but presenting some fragility and medium risk of falls; (3) TUG greater than 20 seconds and less than 30 seconds - individual in need of intervention; (4) TUG greater than 30 seconds - individual at high risk for falls and with impaired mobility |
| Parkinson's Disease Questionnaire (PDQ-39) | 8 weeks | 39 items divided into 8 domains. The total score ranges from 0 to 100, in which a lower score denotes a better perception of the patient's. It is divided into eight categories: mobility (10 items), daily life activities (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (3 items) and body discomfort (3 items) .43 The score ranges from 0 (no problem) to 100 (maximum problem level), ie low score indicates the individual's perception of a better quality of life .. These items can be grouped into three domains: physical, mental and social. The score is made by rule of three and transformed into values from 0 to 100, and higher values refer to poorer quality of life. |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exercises A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training; | 14 |
| Nintendo Wii Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.
The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game | 13 |
| Exercises and Nintendo Wii Exercises and Nintendo Wii: A program of therapeutic exercises (GC) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). The GC treatment program consists of the following protocols: a) protocol 1 : 30 minutes diagonal exercise upper limb, 10 minutes diagonal exercise scapula and 20 minutes 20 minutes of extension exercises for the trunk; b) protocol 2: 20 minutes diagonal exercise lower limb,10 minutes diagonal exercise pelvis, and 10 minutes gait cycle training. Nintendo Wii program (GW) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). Protocol 1 games (Boxing e Soccer); b) protocol 2 games (Golf and Running). In GCW program will be performed 20 minutes G0 protocol (1 or 2, used alternately between sessions a week) and 20 minutes G1 protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols. | 14 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 | 1 |
Baseline characteristics
| Characteristic | Exercises | Nintendo Wii | Exercises and Nintendo Wii | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 10 Participants | 10 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 3 Participants | 4 Participants | 11 Participants |
| Age, Continuous | 64.5 years STANDARD_DEVIATION 9.8 | 61.7 years STANDARD_DEVIATION 7.3 | 66.6 years STANDARD_DEVIATION 8.2 | 64.2 years STANDARD_DEVIATION 8.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 10 Participants | 10 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 3 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 9 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 13 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 13 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 | 0 / 14 |
Outcome results
Berg Balance Scale
It is a scale that allows a functional assessment of the balance of the performance. It is based on 14 common items of everyday life, graduated from 0 to 4 points, reaching 56 points maximum score. It presents test reliability and re-test of 98%, another particularity of the scale is the non-linear relationship between the score and the risk of corresponding falls. The scores range from 0 to 56, the higher the score, the better the assessed individual's balance. Each point less on the scale corresponds to an increased risk of falls; between scores 56 to 54, each minus point is associated with a 3 to 4% increase in the risk of falls; between 54 and 46 an increase of 6 to 8% of chances for each point, being that below 36 points the risk of falls is almost 100%
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercises | Berg Balance Scale | After | 45.6 Score on a scale | Standard Deviation 5.4 |
| Exercises | Berg Balance Scale | Before | 40.5 Score on a scale | Standard Deviation 5.6 |
| Nintendo Wii | Berg Balance Scale | Before | 43.9 Score on a scale | Standard Deviation 5.3 |
| Nintendo Wii | Berg Balance Scale | After | 49.2 Score on a scale | Standard Deviation 4.4 |
| Exercises and Nintendo Wii | Berg Balance Scale | After | 47.1 Score on a scale | Standard Deviation 5.4 |
| Exercises and Nintendo Wii | Berg Balance Scale | Before | 41.6 Score on a scale | Standard Deviation 5.9 |
Dynamic Gait Index - DGI
It is a scale that allows a functional assessment of the balance of the performance. Comprising 8 tasks with a score ranging from 0 to 3 points, maximum score of 24 points and minimum score of 0 points It consists of eight tasks involving walking in different sensory contexts, which include flat surface, change in gait speed, horizontal and vertical head movements, overpassing and bypassing obstacles, turning over the body axis itself, going up and down stairs . The maximum score is 24 points, and a score of 19 points or less predicts risk of falls. The scale has no gaps, only cutoff points. The higher the value, the better the gait performance. For patients with Parkinson's disease, values below 19 points predict major gait problems and high risk of falls.
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercises | Dynamic Gait Index - DGI | Before | 15.6 Units on a scale | Standard Deviation 4.7 |
| Exercises | Dynamic Gait Index - DGI | After | 17.6 Units on a scale | Standard Deviation 3.6 |
| Nintendo Wii | Dynamic Gait Index - DGI | Before | 15.7 Units on a scale | Standard Deviation 2.9 |
| Nintendo Wii | Dynamic Gait Index - DGI | After | 19 Units on a scale | Standard Deviation 3.1 |
| Exercises and Nintendo Wii | Dynamic Gait Index - DGI | Before | 15.8 Units on a scale | Standard Deviation 1.9 |
| Exercises and Nintendo Wii | Dynamic Gait Index - DGI | After | 19.5 Units on a scale | Standard Deviation 2.2 |
Parkinson's Disease Questionnaire (PDQ-39)
39 items divided into 8 domains. The total score ranges from 0 to 100, in which a lower score denotes a better perception of the patient's. It is divided into eight categories: mobility (10 items), daily life activities (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (3 items) and body discomfort (3 items) .43 The score ranges from 0 (no problem) to 100 (maximum problem level), ie low score indicates the individual's perception of a better quality of life .. These items can be grouped into three domains: physical, mental and social. The score is made by rule of three and transformed into values from 0 to 100, and higher values refer to poorer quality of life.
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Exercises | Parkinson's Disease Questionnaire (PDQ-39) | After | 25.7 Score on a scale |
| Exercises | Parkinson's Disease Questionnaire (PDQ-39) | Before | 32.7 Score on a scale |
| Nintendo Wii | Parkinson's Disease Questionnaire (PDQ-39) | Before | 37.1 Score on a scale |
| Nintendo Wii | Parkinson's Disease Questionnaire (PDQ-39) | After | 29.7 Score on a scale |
| Exercises and Nintendo Wii | Parkinson's Disease Questionnaire (PDQ-39) | After | 23.5 Score on a scale |
| Exercises and Nintendo Wii | Parkinson's Disease Questionnaire (PDQ-39) | Before | 32.9 Score on a scale |
Timed Up and Go - TUG
The TUG measures, in seconds, the time it takes an individual to lift from a standard armchair (height of approximately 46 cm), walk a distance of 3 meters, turn, walk back to the chair and sit again. The patient is asked to lift from a chair (seat height of 45 cm and arms from 65 cm) to walk 3 meters, return and sit again, while the time spent in performing this task is timed. TUG up to ten seconds - individual without change of balance and with low risk of falls; (2) TUG between 11 and 20 seconds - individual with no significant alteration of balance, but presenting some fragility and medium risk of falls; (3) TUG greater than 20 seconds and less than 30 seconds - individual in need of intervention; (4) TUG greater than 30 seconds - individual at high risk for falls and with impaired mobility
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercises | Timed Up and Go - TUG | After | 8.2 Seconds | Standard Deviation 2.5 |
| Exercises | Timed Up and Go - TUG | Before | 10.7 Seconds | Standard Deviation 3.6 |
| Nintendo Wii | Timed Up and Go - TUG | Before | 11.5 Seconds | Standard Deviation 5.1 |
| Nintendo Wii | Timed Up and Go - TUG | After | 8.5 Seconds | Standard Deviation 2.1 |
| Exercises and Nintendo Wii | Timed Up and Go - TUG | Before | 13.9 Seconds | Standard Deviation 2.5 |
| Exercises and Nintendo Wii | Timed Up and Go - TUG | After | 10.6 Seconds | Standard Deviation 2.5 |